The European Commission (EC) has approved Takeda’s Fruzaqla (fruquintinib) as a monotherapy for adults with metastatic colorectal cancer who have exhausted currently available standard therapies.

This approval is for patients who have advanced on or are not tolerant to treatments including trifluridine-tipiracil and regorafenib.

In April 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use.

The latest development comes after the US Food and Drug Administration (FDA) granted approval for the same indication in November 2023.

The approval is based on data from the Phase III multi-regional FRESCO-2 trial assessing Fruzaqla along with best supportive care (BSC) versus placebo plus BSC.

The trial met all primary and key secondary efficacy endpoints with the treatment demonstrating benefit regardless of patients' previous therapy types.

The oral inhibitor had a manageable safety profile with adverse reactions that led to discontinuation of treatment.

Takeda holds the sole global licence for developing, marketing and manufacturing fruquintinib outside mainland China, Hong Kong and Macau.

A submission for Fruzaqla was made to the Japan Pharmaceuticals and Medical Devices Agency in September 2023.

Fruquintinib is developed and marketed by Hutchmed in China.

It was first approved by the China National Medical Products Administration in September 2018 and commercially launched in China in November of the same year under the brand name ELUNATE.

Takeda Global oncology business unit president Teresa Bitetti stated: “The approval marks an important moment for the colorectal cancer community in the EU. For the first time in over a decade, patients with previously treated metastatic colorectal cancer have a new targeted treatment option that can be used irrespective of whether their tumours harbour actionable mutations.”